Lung CancerNCT02502240
ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)
An observational study of Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries. Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- How many people
- 7,000 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2015to Dec 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both: both female and male participants are being studied Analysis of the ALK translocation was done either by FISH, IHC, or both, with an adequate amount of cancer cells. Demographic, clinical and pathological data was obtained from patients.
Who may be able to join
- Histologically confirmed lung cancer and tissue availability for ALK analysis.
Who cannot join
- Not lung cancer
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Cancer Institute of Mexico
Mexico City, Mexico City, 14080
Oscar G Arrieta, MD M Sc., 56 28 04 00 ext. 353, ogar@unam.mx
Graciela Cruz Rico, M Sc., 5528880264, gracielacr@hotmail.com
About this study
Official title: Frequency of ALK Rearrangements in Non Small-Cell Lung Cancer in Latin America: The Latin-American Consortium for the Investigation of Lung Cancer (CLICaP).
Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.
Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.
Read the detailed description
The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.
The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.
- Conditions
- Lung Cancer
- Keywords
- ALK, Latin American
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaplastic Lymphoma Kinase (ALK) tumor rearrangement status in Non-Small Cell Lung Cancer (NSCLC) patients
Positive or negative status. Evaluated by three diagnostic methods: (1) fluorescence in situ hybridization (FISH), (2) immunohistochemistry (IHC) and (3) real-time polymerase chain reaction (RT-qPCR).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar Gerardo Arrieta Rodriguez, MD MSc, Principal investigator, Instituto Nacional de Cancerología Mexico city
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502240
- Sponsor's protocol ID
- ALK-CLICaP
- Status last verified
- Mar 2017
- First submitted
- 13 Jul 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Takeuchi K, Choi YL, Soda M, Inamura K, Togashi Y, Hatano S, Enomoto M, Takada S, Yamashita Y, Satoh Y, Okumura S, Nakagawa K, Ishikawa Y, Mano H. Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res. 2008 Oct 15;14(20):6618-24. doi: 10.1158/1078-0432.CCR-08-1018.
PubMed 18927303Lopes LF, Bacchi CE. Anaplastic lymphoma kinase gene rearrangement in non-small-cell lung cancer in a Brazilian population. Clinics (Sao Paulo). 2012 Jul;67(7):845-7. doi: 10.6061/clinics/2012(07)23. No abstract available.
PubMed 22892933Arrieta O, Cardona AF, Martin C, Mas-Lopez L, Corrales-Rodriguez L, Bramuglia G, Castillo-Fernandez O, Meyerson M, Amieva-Rivera E, Campos-Parra AD, Carranza H, Gomez de la Torre JC, Powazniak Y, Aldaco-Sarvide F, Vargas C, Trigo M, Magallanes-Maciel M, Otero J, Sanchez-Reyes R, Cuello M. Updated Frequency of EGFR and KRAS Mutations in NonSmall-Cell Lung Cancer in Latin America: The Latin-American Consortium for the Investigation of Lung Cancer (CLICaP). J Thorac Oncol. 2015 May;10(5):838-843. doi: 10.1097/JTO.0000000000000481.
PubMed 25634006
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of ALK Rearrangements in Non Small-Cell Lung Cancer in Latin America: The Latin-American Consortium for the Investigation of Lung Cancer (CLICaP).
- ClinicalTrials.gov ID
- NCT02502240
- Acronym / sponsor ID
- ALK-CLICaP
- Conditions
- Lung Cancer
- Keywords
- ALK, Latin American
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.
Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.
Detailed description
The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.
The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both: both female and male participants are being studied Analysis of the ALK translocation was done either by FISH, IHC, or both, with an adequate amount of cancer cells. Demographic, clinical and pathological data was obtained from patients.
Key inclusion criteria (1 listed)
- Histologically confirmed lung cancer and tissue availability for ALK analysis.
Key exclusion criteria (1 listed)
- Not lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anaplastic Lymphoma Kinase (ALK) tumor rearrangement status in Non-Small Cell Lung Cancer (NSCLC) patients
Time frame: 1 year
Positive or negative status. Evaluated by three diagnostic methods: (1) fluorescence in situ hybridization (FISH), (2) immunohistochemistry (IHC) and (3) real-time polymerase chain reaction (RT-qPCR).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 18927303Takeuchi K, Choi YL, Soda M, Inamura K, Togashi Y, Hatano S, Enomoto M, Takada S, Yamashita Y, Satoh Y, Okumura S, Nakagawa K, Ishikawa Y, Mano H. Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res. 2008 Oct 15;14(20):6618-24. doi: 10.1158/1078-0432.CCR-08-1018.
- Background: PubMed 22892933Lopes LF, Bacchi CE. Anaplastic lymphoma kinase gene rearrangement in non-small-cell lung cancer in a Brazilian population. Clinics (Sao Paulo). 2012 Jul;67(7):845-7. doi: 10.6061/clinics/2012(07)23. No abstract available.
- Background: PubMed 25634006Arrieta O, Cardona AF, Martin C, Mas-Lopez L, Corrales-Rodriguez L, Bramuglia G, Castillo-Fernandez O, Meyerson M, Amieva-Rivera E, Campos-Parra AD, Carranza H, Gomez de la Torre JC, Powazniak Y, Aldaco-Sarvide F, Vargas C, Trigo M, Magallanes-Maciel M, Otero J, Sanchez-Reyes R, Cuello M. Updated Frequency of EGFR and KRAS Mutations in NonSmall-Cell Lung Cancer in Latin America: The Latin-American Consortium for the Investigation of Lung Cancer (CLICaP). J Thorac Oncol. 2015 May;10(5):838-843. doi: 10.1097/JTO.0000000000000481.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Gerardo Arrieta Rodriguez, MD MSc principal investigator
Instituto Nacional de Cancerología Mexico city
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Gerardo Arrieta Rodriguez, MD MSc (+52 55 6280400 ext. 37045, ogarrieta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaplastic Lymphoma Kinase (ALK) tumor rearrangement status in Non-Small Cell Lung Cancer (NSCLC) patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.